1. Field of the Invention
The invention relates to an insufflation pump.
2. Description of the Related Art
Most vascular procedures are now performed in an endovascular fashion; that is, by way of a catheter placed inside of an artery or vein. The benefit of an endovascular, versus a traditional “open”, surgical procedure is the greatly decreased morbidity and mortality afforded by the endovascular route, while affording similar overall outcomes. Instead of the traditional surgical bypass procedure performed on the heart, legs, as well as other body parts, endovascular percutaneous transluminal angioplasty, or PTA, is now the standard of care for treating narrowed or blocked arteries and veins. Angioplasty is performed to dilate arteries, veins and other closed, tubular structures within the body. These additional structures may include the biliary tree, ureters, kidneys, as well as other tissue which needs to be expanded radially. Its worldwide acceptance has resulted in millions of PTA, or “angioplasty” procedures performed in the United States and abroad yearly.
When performing angioplasty, the physician advances a specialized catheter, which contains a pre-mounted balloon at its tip, over a guide wire and into the area of abnormal narrowing in the artery or vein. This catheter advancement is accomplished utilizing fluoroscopic guidance, which is essentially a “real time” continuous x-ray image. Once the balloon or angioplasty catheter is precisely placed into the desired area within the blood vessel, the catheter-mounted balloon can be inflated, thusly performing angioplasty within the artery or vein. The inflation of the balloon is accomplished by the use of a device known as an insufflator.
All currently-available insufflators require two hands to inflate the balloon: one to hold the device and one to incrementally increase the fluid forced into the balloon from the insufflator by rotating a threaded screw. A pressure gauge is commonly located on the body of the insufflator so that the balloon can be inflated to a desired atmospheric pressure. The use of an insufflator, as opposed to a simple syringe, results in accurate, reproducible pressures within the angioplasty balloon. Because operation of the insufflator requires two hands, a second physician, or technician, is needed to hold the angioplasty catheter in the proper position during the angioplasty procedure and inflation of the balloon. The primary physician must, therefore, decide which portion of the procedure is most important; that is, controlling inflation rates and pressures in operating the insufflator versus controlling the positioning of the balloon catheter. Not properly positioning the angioplasty balloon may result in damage to a normal portion of the vessel, while not holding the catheter in place could result in undesired movement of the angioplasty balloon, with subsequent traumatic vessel dissection. This results in, as a best-case scenario, inadequate angioplasty due to improper balloon placement, or in the worse scenario, vessel dissection and possible death.
Most recently, with the advent of balloon kyphoplasty for the repair of vertebral compression fractures of the spine, balloon catheters have also been used to expand compressed bone. These procedures similarly require the use of an insufflator in the inflation of the balloon catheter and are consequently beset with the same problems.
Currently, insufflators are filled with a mixture of radiopaque contrast material and sterile saline during a procedure. This mixture allows the angioplasty balloon to be observed under fluoroscopy by the operating physician, and its precise location can be directly observed in real time. In addition, the response of the vessel to angioplasty can be monitored indirectly by viewing the form of the angioplasty balloon using fluoroscopy: a narrow balloon suggests a poorly dilated vessel while a fully expanded balloon suggests a successfully dilated vessel.
With the foregoing in mind, an insufflator adapted for one-handed operation has been developed; as such, it is both held and deployed utilizing one hand as opposed to two. By allowing one hand to be freed, the physician can thusly hold the catheter in its proper position, while controlling both the rate of pressure rise and total pressure achieved by inflation of the angioplasty catheter.